India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Humira faces up to intense biosimilar competition
The early signs of biosimilar competition for Humira appear to confirm that this is a watershed, global event for the biosimilars market - with intense competition arriving at an unprecedented rate. A sign of things to come has already arrived in countries such as Denmark and Italy.
On 20 November, Denmark's regional procurement organization, Amgros, announced preliminary results from two tender competitions for Humira - and Amgros immediately indicated that AbbVie's reference product Humira "does not have the lowest price" and is thus "not the winner with the highest ranking". Amgros representatives stated that offers were received from five pharmaceutical companies in both competitions. The prices submitted and the ranking of companies will not be disclosed until 1 January 2019 and 1 April 2019, respectively. However, the two tender contracts were for different time periods from January to March 2019 and from April to December 2019 (with an option to extend the arrangement further). The national tender for Humira in Denmark is a further indication of the intense pricing pressure that AbbVie is encountering from biosimilar competitors. The full details of the contract will not be revealed by Amgros until the first quarter of 2019. Nevertheless, the preliminary results are likely to have knock-on consequences in other EU markets - as a benchmark for other tenders and for countries that use Denmark in international reference pricing (IRP) baskets. Regional authorities in Denmark have forecast that the introduction of cheaper biosimilar versions of Humira in the hospital system will generate savings of at least DKK335 million (USD51 million) next year.
Separately - but on the same day - reports emerged in Italy that five regional authorities - Piedmont, Valle d'Aosta, Lazio, Sardinia, and Veneto - have joined forces to conduct a single tender for the biosimilar versions of Humira, which generates local sales amounting to EUR285.0 million. Italy's public procurement agency, CONSIP, will conduct the tender on behalf of the five regional administrations, and the cost to regional authorities involved is set to fall from EUR47 million previously to approximately EUR16 million, down 65%. The region tender offer will serve as a good basis for gauging the cost savings and price competition that Humira biosimilars can generate in Italy. Biosimilars uptake in Italy has been increasing during recent years, although there remain strong regional variations, and the fact that regions are now banding together for tenders is precisely designed to counteract these variations.
Clearly, this is only the beginning, and many of the bigger markets are still assessing their approach to biosimilar adalimumab. But the early signs are that payors at both national and regional level are taking unprecedented steps to encourage price competition among the new biosimilars, with Europe again leading the way - although the FDA is also pushing through biosimilar approvals in this area.
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